A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Narcolepsy

Treatments: Drug: Placebo; Drug: ADX-N05

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485770

ADX-N05 201

Details and patient eligibility

About

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of narcolepsy
• Good general health
• Willing and able to comply with the study design and schedule and other requirements

Exclusion criteria

• If female, pregnant or lactating
• Customary bedtime later than midnight
• History of significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history
• Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
• History of significant cardiovascular disease
• Body mass index >34
• Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day
• History of alcohol or drug abuse within the past two years
• Nicotine dependence that has an affect on sleep

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 2 patient groups, including a placebo group

Placebo, Then ADX-N05

Experimental group

Description:

Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).

Treatment:

Drug: ADX-N05

Drug: Placebo

ADX-N05, Then Placebo

Placebo Comparator group

Description:

Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).

Treatment:

Drug: ADX-N05

Drug: Placebo